FARYDAK- panobinostat capsule

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

PANOBINOSTAT LACTATE (UNII: HN0T99OO4V) (PANOBINOSTAT - UNII:9647FM7Y3Z)

थमां उपलब्ध:

Novartis Pharmaceuticals Corporation

INN (इंटरनेशनल नाम):

PANOBINOSTAT LACTATE

रचना:

PANOBINOSTAT 10 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

FARYDAK, a histone deacetylase inhibitor, in combination with bortezomib and dexamethasone, is indicated for the treatment of patients with multiple myeloma who have received at least 2 prior regimens, including bortezomib and an immunomodulatory agent. This indication is approved under accelerated approval based on progression free survival [see Clinical Studies (14.1)] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. None Risk Summary FARYDAK can cause fetal harm when administered to a pregnant woman. Panobinostat was teratogenic in rats and rabbits. If FARYDAK is used during pregnancy or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus. Data Animal Data In embryofetal development studies, panobinostat was administered orally 3 times per week during the period of organogenesis to pregnant rats (30, 100, and 300 mg/kg) and rabbits (10, 40, and 80 mg/kg). I

उत्पाद समीक्षा:

How Supplied FARYDAK 10 mg panobinostat (equivalent to 12.58 mg of panobinostat lactate): Size # 3 light green opaque capsule, radial markings on cap with black ink “LBH 10 mg” and two radial bands with black ink on body, containing white to almost white powder. FARYDAK 15 mg panobinostat (equivalent to 18.86 mg of panobinostat lactate): Size #1 orange opaque capsule, radial markings on cap with black ink “LBH 15 mg” and two radial bands with black ink on body, containing white to off-white powder. FARYDAK 20 mg panobinostat (equivalent to 25.15 mg of panobinostat lactate): Size #1 red opaque capsule, radial markings on cap with black ink “LBH 20 mg” and two radial bands with black ink on body, containing white to off-white powder. FARYDAK capsules are packaged in PVC/PCTFE blister packs. 10 mg Blister packs containing 6 capsules ………………………….…….NDC 0078-0650-06 15 mg Blister packs containing 6 capsules ………………………….…….NDC 0078-0651-06 20 mg Blister packs containing 6 capsules ………………………….…….NDC 0078-0652-06 Storage and Handling Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F). Store blister pack in original carton to protect from light. FARYDAK capsules should not be opened, crushed, or chewed. Direct contact of the powder in FARYDAK capsules with the skin or mucous membranes should be avoided. If such contact occurs wash thoroughly. Personnel should avoid exposure to crushed and/or broken capsules. FARYDAK is a cytotoxic drug. Follow special handling and disposal procedures [see References (15)1 ] .

प्राधिकरण का दर्जा:

New Drug Application

सूचना पत्रक

Novartis Pharmaceuticals Corporation
----------
This Medication Guide has been approved by the U.S. Food
and Drug Administration.
Revised: June 2016
MEDICATION GUIDE
FARYDAK® (FAYR-ah-dak)
(panobinostat) capsules
What is the most important information I should know about FARYDAK?
FARYDAK can cause serious side effects, including:
• Diarrhea is common with FARYDAK and can be severe. Tell your
healthcare provider right away if you
have abdominal (stomach) cramps, loose stool, diarrhea, or if you feel
like you are becoming dehydrated.
Your healthcare provider may prescribe medicines to help prevent or
treat these side effects. Taking or using
stool softeners or laxative medicines may worsen diarrhea, talk to
your healthcare provider before taking or
using these medicines.
Your healthcare provider will do regular tests to check the levels of
fluid and electrolytes in your blood
during treatment with FARYDAK.
• Heart problems. FARYDAK can cause severe heart problems which can
lead to death. Your risk of heart
problems may be increased if you have a condition called “long QT
syndrome” or other heart problems.
Your healthcare provider will do blood tests to check your
electrolytes and do an electrocardiogram (ECG)
tests before and during treatment with FARYDAK. Call your healthcare
provider and get emergency
medical help right away if you have any of the following symptoms of
heart problems:
o chest pain
o dizziness
o faster or slower heart beat
o blue colored lips
o palpitations (feel like your heart is racing)
o shortness of breath
o feel lightheaded or faint
o swelling in your legs
• Bleeding. FARYDAK can cause severe bleeding which can lead to
death. It may take you longer than
usual to stop bleeding while you are taking FARYDAK. Your healthcare
provider will check your platelet
counts before you start FARYDAK and during your treatment with
FARYDAK. Tell your healthcare
provider right away if you get any of the following signs of bleeding:
o blood in your stools or black stools (look like tar)
o increased

उत्पाद विशेषताएं

FARYDAK- PANOBINOSTAT CAPSULE
NOVARTIS PHARMACEUTICALS CORPORATION
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FARYDAK SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FARYDAK.
FARYDAK (PANOBINOSTAT) CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2015
WARNING: FATAL AND SERIOUS TOXICITIES: SEVERE DIARRHEA AND CARDIAC
TOXICITIES
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
SEVERE DIARRHEA OCCURRED IN 25% OF FARYDAK TREATED PATIENTS. MONITOR
FOR
SYMPTOMS, INSTITUTE ANTI-DIARRHEAL TREATMENT, INTERRUPT FARYDAK AND
THEN REDUCE
DOSE OR DISCONTINUE FARYDAK. (5.1)
SEVERE AND FATAL CARDIAC ISCHEMIC EVENTS, SEVERE ARRHYTHMIAS, AND ECG
CHANGES
HAVE OCCURRED IN PATIENTS RECEIVING FARYDAK. ARRHYTHMIAS MAY BE
EXACERBATED BY
ELECTROLYTE ABNORMALITIES. OBTAIN ECG AND ELECTROLYTES AT BASELINE AND
PERIODICALLY
DURING TREATMENT AS CLINICALLY INDICATED. (5.2)
RECENT MAJOR CHANGES
Warnings and Precautions, Embryo-Fetal Toxicity (5.7)
6/2016
INDICATIONS AND USAGE
FARYDAK, a histone deacetylase inhibitor, in combination with
bortezomib and dexamethasone, is
indicated for the treatment of patients with multiple myeloma who have
received at least 2 prior regimens,
including bortezomib and an immunomodulatory agent. This indication is
approved under accelerated
approval based on progression free survival. Continued approval for
this indication may be contingent
upon verification and description of clinical benefit in confirmatory
trials. (1)
DOSAGE AND ADMINISTRATION
20 mg, taken orally once every other day for 3 doses per week (on Days
1, 3, 5, 8, 10, and 12) of Weeks
1 and 2 of each 21-day cycle for 8 cycles (2.1)
Consider continuing treatment for an additional 8 cycles for patients
with clinical benefit, unless they
have unresolved severe or medically significant toxicity (2.1)
DOSAGE FORMS AND STRENGTHS
Capsules: 10 mg, 15 mg, and 20 mg panobinostat (equivalent to 12.58
mg, 18.86 mg, and 25.15 mg
respectively of panobinostat lactate) (3